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NCT07020117 · ClinicalTrials.gov registry record · Phase 1
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Cancer, sponsored by Aktis Oncology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 9
- Study locations
NCT07020117 is a Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Cancer that is actively recruiting participants, run by Aktis Oncology. The registered enrollment target is 150 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (77% lower). The trial reports 9 study locations across 8 states.
The verdict
NCT07020117, a Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Cancer, is actively recruiting participants, sponsored by Aktis Oncology.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.
Conditions Studied
Interventions
- DRUG [225Ac]Ac-AKY-1189 (therapeutic)
- DRUG [64Cu]Cu-AKY-1189 (imaging)
Study Locations (9)
California
- City of Hope - Duarte
- Hoag Memorial Hospital Presbyterian - Irvine
Florida
- Biogenix Molecular, LLC - Miami
Iowa
- University of Iowa - Iowa City
Maryland
- United Theranostics - Glen Burnie
Michigan
- BAMF Health - Grand Rapids
New York
- Icahn School of Medicine at Mt. Sinai - New York
Pennsylvania
- UPMC - Pittsburgh
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-08-22 |
| Est. Completion | 2032-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07020117
The ClinicalTrials.gov registry entry for NCT07020117 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (77% lower). The listed sponsor is Aktis Oncology, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which [225Ac]Ac-AKY-1189 (therapeutic) is the first listed.
NCT07020117 reports 9 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Iowa.
Frequently Asked Questions
What is clinical trial NCT07020117 about?
NCT07020117 is a clinical study titled "A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors". This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administ...
What is the current status of trial NCT07020117?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2025-08-22. Estimated completion is 2032-06.
What conditions does trial NCT07020117 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Head and Neck Cancer, Colorectal Adenocarcinoma, Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC).
What interventions are being tested in trial NCT07020117?
The interventions under investigation include: [225Ac]Ac-AKY-1189 (therapeutic) (DRUG), [64Cu]Cu-AKY-1189 (imaging) (DRUG).
Who is sponsoring clinical trial NCT07020117?
This trial is sponsored by Aktis Oncology, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07020117 being conducted?
This trial has 9 study locations across California, Florida, Iowa, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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